Eligibility criteria

The following types of studies will be considered for an Vascular IIR Research Program grant:

Clinical studies involving adults aged >18 years

Laboratory research, including ex vivo, in vitro and preclinical models

Eligible areas of research

The Vascular IIR Research Program review committee will consider proposals for research projects that address the mode of action of rivaroxaban and/or the involvement of Factor Xa or thrombin in vascular protection in one of the following areas, related to CAD, PAD or heart failure (HF) with CAD:

Athero-inflammation and cell signaling

Atherosclerotic plaque development

Atherosclerotic plaque stability

Atherothrombosis

Cardioprotection/myocardial remodeling

Cytoprotection/apoptosis

Endothelial dysfunction

Platelet activation and aggregation

Synergistic antiplatelet and anticoagulation effects

Ventricular remodeling

Biomarkers in CAD, PAD and HF with CAD

Non-eligible areas of research

Areas of research NOT eligible for an Vascular IIR Research Program grant include:

Patient populations where the risk of rivaroxaban use is greater than the benefit

Use that is contraindicated according to the local label recommendations for rivaroxaban, e.g. pregnant and lactating women

Use of dosing regimens outside of the local label recommendations for rivaroxaban

Repetition/duplication of research, including any phase III trials or studies listed for rivaroxaban in clinicaltrials.gov

Proposals previously rejected by Bayer

Additional submission criteria

The 2018 Vascular IIR Research Program is open to global investigators

All research must be conducted in accordance with the global and local regulatory, legal and ethical guidelines, including posting on a clinical trial registry where appropriate

Investigators and/or their affiliated institutions assume responsibility for all aspects of the study, including design, regulatory approval, initiation, conduct and monitoring of the study, as well as for the analysis and publication of study results

The awarded grant will match the study budget requirements up to €250,000; in exceptional cases, a higher budget may be considered

The principal investigator is not receiving or will not receive any other sources of funding for the submitted research proposal

The study must start within 6 months of contract execution, and results should be available within 1.5 years of study initiation; in exceptional cases, studies of a longer duration may be considered

All funded research should merit submission to scientific meetings as an abstract and subsequent publication in a peer-reviewed journal